Document Processor I

I. JOB SUMMARY: 
 Drive document control activities on the various product lines at Philips Volcano including; processing documentation changes for operations, R&D and quality, working with the document control process owner to continuously improve and align document control process and implement lean practices. Coordinates and maintains device history, history files, product design files and training files. 
 
 
 II. JOB DUTIES/RESPONSIBILITIES: 
 
 Activity 
 Support change task authors and process owners in defining and producing Quality System documents and records; ensure proper quality of the content of documentation and records 
 Provide on time collaboration and required support for all recurring NPIs and other sustaining changes. 
 Approve Change Tasks in PLM system in a timely manner 
 Coordinate implementation dates with assignees 
 
 Provide guidance to Change Management users for change's submission 
 Provide Change Management trainings for new users 
 Elaborate supporting material for Change Management users (Visual Aids, checklists, etc) 
 
 Maintain proper document review processes 
 Reviews completeness of documentation 
 Ensures availability/publishing of controlled documents 
 Maintains document control files and records. Archives Device History Records, Lot History Records, Master Device Records, Training Records, etc. 
 Apply test in Quality Management System trainings where is a qualified trainer. 
 Additional functions may be essential as designated by the Supervisor 
 
 
 III. REQUIREMENTS: 
 
 EDUCATION: 
 • Associates degree in business, sciences or related field, or equivalent professional experience 
 
 KNOWLEDGE AND EXPERIENCE: 
 • Knowledge of computer applications (i.e.: Microsoft Word, Excel, PowerPoint, Access & Project, Windows, Visio, etc.) required 
 • Knowledge of regulated industries; familiarity with ISO 13485:2016, FDA Good Documentation Practices 
 • 1 to 2 years related experience in change control and or document control field Working knowledge of change management and document control processes 
 • Ability to operate efficiently and effectively in a fast-paced environment 
 • Knowledge of and ability to work within a global corporate environment is required. Highly collaborative. 
 • Ability to communicate at all levels of an organization effectively 
 
 LICENSES AND CERTIFICATIONS: 
 • None 
 
 ADDITIONAL DESIRABLE QUALIFICATIONS: 
 • Document Control experience preferred 
 • Experience using PLM and training systems preferred 
 • Experience with Interfacing with regulatory bodies preferred 
 
 SKILLS AND ABILITIES: 
 • Ability to communicate effectively both orally and in writing and to establish and maintain cooperative working relationships with persons contacted in the course of performing assigned duties including Company management and outside business associates 
 • Strong attention to detail 
 • Ability to maintain confidentiality 
 • Organizational skills and ability to prioritize workflow to meet established timeframes 
 • Ability to maintain updated knowledge of procedures, products and activities of assigned area 
 • Ability to accurately proofread documents 
 • Demonstrated understanding of FDA Good Documentation Practices (GDP) 
 • •Clear and effective communication skills 
 
 PROBLEM SOLVING AND DECISION MAKING: 
 • Follows specific, detailed process instructions; ability to troubleshoot and problem solve effectively. Defers to supervisor when required. 
 
 
 SUPERVISORY RESPONSIBILITY: 
 • None 

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